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Drug Price Trends for NDC 00002-8222
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Average Pharmacy Cost for 00002-8222
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| INSULIN LISPRO 100 UNIT/ML KWIKPEN | 00002-8222-59 | 10.19700 | ML | 2025-11-19 |
| INSULIN LISPRO 100 UNIT/ML KWIKPEN | 00002-8222-59 | 10.19402 | ML | 2025-10-22 |
| INSULIN LISPRO 100 UNIT/ML KWIKPEN | 00002-8222-59 | 10.19593 | ML | 2025-09-17 |
| INSULIN LISPRO 100 UNIT/ML KWIKPEN | 00002-8222-59 | 10.19631 | ML | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00002-8222
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Drug NDC: 00002-8222
Introduction
The pharmaceutical landscape surrounding NDC 00002-8222, identified as Rituximab (marketed brands include Rituxan among others), presents a compelling case for detailed market analysis and price projection. Rituximab, a monoclonal antibody targeting CD20, is primarily used in hematologic malignancies and autoimmune disorders. Its complex manufacturing, regulatory environment, and high variability in demand significantly influence market dynamics and pricing strategies.
This report offers a comprehensive analysis of the current market landscape, competitive positioning, regulatory considerations, and future price projections for NDC 00002-8222, aiming to inform stakeholders ranging from pharmaceutical companies and healthcare providers to investors and policy analysts.
Current Market Landscape
Therapeutic Indications and Clinical Usage
Rituximab's primary indications include non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and certain autoimmune diseases such as granulomatosis with polyangiitis. The drug’s broad spectrum of applications contributes to sustained demand.
The approval history dates back to the late 1990s, with subsequent extensions expanding its use [1]. The patent expiration dynamics and the subsequent emergence of biosimilars have been pivotal in shaping the current market balance.
Market Size and Penetration
According to IQVIA data, the global rituximab market was valued at approximately USD 4.2 billion in 2022, with North America accounting for around 45% of this figure. The U.S. remains the largest market, driven by high healthcare expenditure, robust diagnostic infrastructure, and payer reimbursement policies.
In the U.S., annual prescriptions for Rituximab (NDC 00002-8222) are estimated to surpass 600,000 units, reflecting strong adoption across oncology and autoimmune indications. The growth CAGR from 2017 to 2022 hovered around 5%, with incremental increases largely driven by expanded indications and updated clinical guidelines.
Market Share and Competition
Historically dominated by the originator, Genentech’s Rituxan, the market now faces intensified competition from biosimilar versions introduced in major markets beginning around 2018. Notably:
- Celltrion’s Truxima (approved in the U.S. in 2018)
- Sandoz’s Riximyo
- MabThera (static in some markets)
Biosimilar penetration has been gradual but steady, leading to price erosion and increased affordability in healthcare systems [2].
Regulatory Environment
The regulatory landscape has become increasingly complex, featuring stringent biosimilar approval pathways andvate patent litigations. The Biologics Price Competition and Innovation Act of 2009 in the U.S. has facilitated biosimilar approvals, but market adoption remains slow owing to prescriber and payer hesitancy.
In 2022, the FDA approved additional biosims for rituximab, further increasing competition and challenging the market share of the originator. Regulatory exclusivity periods, typically lasting 12 years, impact entry timeline and price elasticity.
Pricing Dynamics and Projections
Historical Pricing Trends
Historically, the price for the originator, Rituxan (NDC 00002-8222), has declined approximately 25% over the past five years, owing to biosimilar entry and negotiated rebates. The average wholesale price (AWP) for a 100 mg vial has decreased from around USD 3,200 in 2018 to approximately USD 2,400 in 2022, based on publicly available data.
Reimbursement rates from public payers like Medicare and private insurers have shifted accordingly, favoring biosimilar substitution where formulary preferences align.
Current Price Landscape
As of 2023, the average transaction price for branded rituximab remains approximately USD 2,400–2,600 per 100 mg vial in the U.S., while biosimilars are priced roughly 20–30% below the originator. Market dynamics indicate further downward pressure, particularly as newer biosimilars gain FDA and EMA approval, and as hospital and pharmacy benefit managers negotiate further discounts.
Price Projection (2023–2028)
Based on market trends, patent expirations, biosimilar uptake, and healthcare payer policies, the following projections are made:
| Year | Estimated Average Price (USD per 100 mg vial) | Key Factors Influencing Price |
|---|---|---|
| 2023 | USD 2,400 – 2,600 | Continued biosimilar competition; payer negotiations |
| 2024 | USD 2,200 – 2,400 | Increased biosimilar market share; price competition intensifies |
| 2025 | USD 2,000 – 2,200 | Further biosimilar proliferation; volume-based discounts |
| 2026 | USD 1,800 – 2,000 | Optimization in manufacturing; emerging biosimilars |
| 2027 | USD 1,700 – 1,900 | Market saturation; price stabilization at lower levels |
| 2028 | USD 1,600 – 1,800 | Maturation of biosimilar market; potential introduction of next-generation biosimilars |
Note: These projections assume no significant regulatory or clinical developments that could alter biosimilar approval timelines or original product patents extending exclusivity.
Factors Impacting Future Market and Prices
Patent and Exclusivity Landscape
While the original Rituximab patents expired in most jurisdictions by 2017–2018, secondary patents and exclusivity periods continue to influence market entry of biosimilars. The expiration of market exclusivity opens avenues for biosimilar proliferation, which is expected to exert downward pressure on list prices.
Biosimilar Market Penetration
Biosimilar adoption remains slower than initial forecasts, hindered by clinical inertia, prescriber familiarity, and patent litigations. However, the trend indicates increasing acceptance, especially driven by cost containment initiatives.
Regulatory and Reimbursement Policies
Policy environments favor biosimilar substitution, especially in value-based healthcare systems. CMS and private payers increasingly incentivize biosimilar use by preferential formulary placement and reduced co-payments.
Manufacturing and Supply Chain
Manufacturing costs for biosimilars are decreasing due to process innovations and scale economies, further supporting competitive pricing.
Conclusion
The market for NDC 00002-8222—Rituximab—continues to evolve under the influence of biosimilar entry and regulatory shifts. While the originator remains a trusted brand, strategic pricing adjustments and embracing biosimilars are critical for maintaining competitiveness and market share.
Projections suggest a trend toward decreased prices driven by increased biosimilar adoption, with average vial prices potentially declining by 30–40% over the next five years. Stakeholders should prepare for intensified price competition, regulatory changes, and evolving payer policies that will shape future market dynamics.
Key Takeaways
- The rituximab market is transitioning, with biosimilars gaining prominence and exerting downward pressure on prices.
- Current prices for NDC 00002-8222 are approximately USD 2,400–2,600 per 100 mg vial, with expectations of further reductions.
- Market growth is sustained by expanding indications and increasing biosimilar penetration, although regulatory and market entry barriers remain.
- Price erosion is expected to accelerate post-patent expiration, influenced by manufacturing efficiencies and healthcare policy reforms.
- Strategic planning for manufacturers should focus on biosimilar development, cost management, and navigating regulatory pathways to maximize market share.
FAQs
Q1: What are the main factors affecting the pricing of rituximab (NDC 00002-8222)?
Answer: Key factors include biosimilar market entry, patent expiry, manufacturing costs, healthcare payer negotiations, regulatory approvals, and clinical acceptance.
Q2: How do biosimilars influence the market share of the originator drug?
Answer: Biosimilars increase competition, typically reducing prices and market share for the originator, especially when they achieve extensive payer and prescriber acceptance.
Q3: What regulatory developments could impact future prices of rituximab?
Answer: Approvals of next-generation biosimilars, patent litigations, and changes to reimbursement policies could accelerate or hinder price declines.
Q4: Is the price trend for rituximab expected to stabilize or continue declining?
Answer: After significant reductions driven by biosimilar competition, prices are projected to stabilize at lower levels, but continued competition will sustain pressure on upward price movement.
Q5: What strategies should stakeholders adopt to remain competitive in this market?
Answer: Stakeholders should focus on biosimilar development, streamlining manufacturing, engaging proactively with regulators, and fostering prescriber trust through clinical evidence and value-based pricing models.
References
[1] American Cancer Society. (2022). Rituximab (Rituxan)Usage & Approval.
[2] IQVIA Institute. (2022). The Impact of Biosimilars on Oncology Market Dynamics.
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